Article
Using 100% Headspace Inspection For Characterizing And Optimizing Parenteral Manufacturing Processes
February 6, 2012
Laser-based headspace analysis provides a rapid nondestructive method for performing trace gas analysis in the headspace of sterile pharmaceutical vials, ampoules, bottles, and syringes. Industry case studies presented here illustrate the value of total headspace characterization for 100% of finished product. Insight is gained into both product quality and the efficiency of the sterile process itself; a correlation that is missed with standard development and validation studies. This additional insight can be used to optimise processes, identify manufacturing issues, and guarantee the quality of finished product with 100% inspection. Headspace parameters of interest in parenteral drug products include headspace oxygen concentrations, water vapor levels, and absolute nitrogen pressure. A primary application is 100% container closure integrity inspection of freeze dried vials. Other important applications include headspace oxygen monitoring on liquid filling lines for optimization and validation of nitrogen purging processes, and 100% moisture determination of finished freeze dried product supporting lyo cycle optimization and freeze dryer validation.
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